Primolut N

Therapeutic indications

Primolut N is a drug in the form of a tablet. In contains norethisterone which is a synthetic form of the natural hormone progesterone. The hormone progesterone is important in women menstrual cycle and fertility like it is important for ovulation and the maintaining of regular periods. The imbalance of the hormone in the body results in a number of problems. The drug is used in the treatment and management of a number of conditions that are as a result of hormonal imbalance. These conditions include:

• Heavy menstrual bleeding
• Menstruation pain
• Endometriosis
• Breast cancer
• Primary and secondary amenorrhea
• Premenstrual syndrome
• Estrogen hormone replacement therapy (menopausal symptoms)
• Delay of the menstrual period
• Irregular periods
• Continuous periods
• Endometrial cancer
• Prevent unwanted pregnancies( a contraceptive)

Do I need a prescription?

Primolut N is available in drug stores and can also be ordered from online drug stores. For the drug to be sold it is mandatory to have a doctor’s prescription.

Dosage

Primolut N should be swallowed whole and taken with a liquid. The recommended dose is different depending on the condition it is prescribed to manage. Recommended doses for a number of conditions include:

• Dysfunctional uterine bleeding: 5 mg (one tablet) three times a day for 10 days. In the case that the bleeding does not stop, other causes need to be considered. To prevent the reoccurrence of the dysfunctional bleeding, 5 mg (one tablet) should be taken 1 to 2 times in a day form the 16^th to the 25^th day of the cycle (1st day of the period being the 1st day of the last bleeding.
• Premenstrual syndrome: 5 mg (one tablet) 1 to 3 times a day during the luteal phase (day 19 to 26 of the cycle).
• Postponement of menstrual bleeding: 5 mg (one tablet) 2 to 3 times a day from day 3 to the expected period. The tablet should be taken for a period not longer than 10 -14 days. Bleeding will be expected 2-3 days after the last dose.
• Endometriosis: 5 mg (one tablet) two times a day between the first and fifth day of the cycle. In the case that spotting occurs the dose should be adjusted to two tablets two times a day when it stops the dose should go back to the initial dose. The tablet should be taken for a period of 4 -6 months at least without interruption. It will stop ovulation and menstruation which will resume when the treatment is withdrawn.
• Menorrhagia (hypermenorrhea): 5 mg (one tablet) 3 times a day starting day 5 to day 25 of the cycle.
• Dysmenorrhea: 5 mg (one tablet) three times a day for 20 days from day five of the cycle. The tablet should be taken for 3 -4 cycles.

Chemical composition

The key ingredient in Primolut N tablets is 5 mg of norethisterone. The tablets also contain magnesium stearate, maize starch, and lactose. Norethisterone is a synthetic form of progesterone a sex hormone. Norethisterone is also called norethindrone in the US.

Mechanism of action (MOA)The synthetic hormone norethisterone has actions that are of a progestin.  Natural progesterone produced by the body prepares the lining of the uterus for implantation of the egg. In the case that no fertilized egg is implanted, the levels of progesterone hormone in the blood reduce and the lining of the uterus is shade. When implantation of a fertilized egg occurs, the levels of progesterone increase so as to maintain the pregnancy.

Norethisterone mimics the actions of progesterone thus is used for normal shedding and healthy growth of the uterus lining. The drug works by preventing the release of an egg from the ovary or ovulation preventing fertilization from occurring. It also alters the endometrium lining preventing a fertilized egg from implanting thus conception does not occur.

When taken a few days to your period, it prevents the periods by tricking the body that you are pregnant. The period resumes when you stop using it.

Contraindications

The use of Primolut N is not recommended in a number of conditions as it could worsen the condition. Inform your doctor if you have or had any of the following conditions as it might affect the dose to be prescribed.

• Hypersensitive to the active ingredient norethisterone or any of the other ingredients. Symptoms of an allergy include shortness of breath, breathing difficulty, rash, hives, and itching on the skin, swelling of lips, throat, tongue, face or other parts of the body.
• If you pregnant or planning to become pregnant. The drug may affect the developing fetus more so if the pregnancy is past day 45 and onwards when the genitalia is developing.
• If you are breastfeeding. Norethisterone has been shown to pass into breast milk and should not be used as its effect of the nursing baby is not clear. It may also suppress milk production.
• If you have ever had a blood clot in the blood vessels of the legs( deep vein thrombosis), the lungs( pulmonary embolism), heart(heart attack), brain(stroke) or any other body parts.
• If you smoke and you are elderly as there is an increased risk of a blood clot forming when taking Primolut N.
• Angina
• Transient ischemic attack
• Diseases of the heart or blood vessels
• A migraine that is accompanied by visual symptoms, weakness, numbness in any body part or disability in speech.
• Diabetes mellitus, Primolut N may increase your blood sugar levels. In the case that you take it, blood sugar levels should be closely monitored.
• Severe disease of the liver, symptoms or liver damage includes itching of the whole body and/or yellowing of the skin. Dose-adjusted is recommended if the disease is not severe.
• A liver tumor that is malignant or benign.
• Breast cancer or genitalia cancers that are sex-hormone dependent.
• Dubin-Johnson syndrome or Rotor syndrome.
• Bleeding in the vagina or blood in urine whose cause is not known
• Breast disease whose cause is not known.
• Miscarriage
• Epilepsy
• Asthma
• Kidney disease
• Psychic depression history
• Antiphospholipid syndrome
• Antithrombin deficiency
• Factor V Leiden
• Obese
• High blood pressure
• High cholesterol levels
• Gallstones
• Hereditary angioedema
• Chloasma
• Sickle cell anemia
• Haemolytic-uraemic syndrome(HUS)
• Systemic lupus erythematosus
• Crohn’s disease or chronic inflammatory bowel syndrome

Side effects

Primolut N causes a number of side effects apart from the desired effects. Some of the side effects only occur at the beginning of using the drug but with continued use, the side effects subside. Some of the side effects are more common but less serious, while others are more serious and rare. Report to your doctor if you experience any of the side effects, more so if they do not go away and may require medical attention.

Common side effects include:

• Dizziness
• Nausea
• A headache
• Breast tenderness
• Irregular menstrual cycle
• Ovarian cysts
• Loss or gaining of weight
• Stomach ache
• Constipation
• Vaginal bleeding that could include spotting and hypermenorrhea
• Amenorrhoea
• Fatigue

Other side effects that may occur include:

• A migraine
• Retention of fluid that may result in edema
• Skin reactions like rashes, acne or itching
• Difficulty sleeping
• Increase in blood pressure
• Changes in sex drive
• Hair loss(alopecia)
• Excessive hair growth( hirsutism)
• Abdominal pain
• Jaundice
• Cholestasis
• Dyspnea
• Thrombophlebitis
• Pulmonary embolism
• Nervousness
• Tremor
• Breast discharge
• High fever
• Cushing’s syndrome

Serious side effects

• Hypersensitive reactions that may cause hives, rashes, shortness of breath and swelling of face, tongue, and lips.
• Blurred vision
• Strong migraines
• Sudden chest pain
• Sudden numbness on one side of the body
• Stabbing pain or swelling occurring in one leg
• Pain while breathing or coughing blood
• Jaundice

If you accidentally take an overdose of the drug, contact your doctor or rash into the nearest emergency medical center carrying the package or label with you. Do this even if you experience no signs of poisoning. An overdose may cause vomiting, nausea, and bleeding from the vagina.

Drug Interactions

Promolut n interacts with a number of drugs. Inform your doctor if you are taking any drugs whether prescribed drugs, over the counter drugs, supplements or vitamins, and any herbal medications. The drugs may affect the working of Primolut N, prevent it from working properly or cause side effects. The interactions include:

• Hepatic enzyme-inducing drugs lower the therapeutic effect of Primolut N as they increase its clearance from blood. These drugs are griseofulvin, oxcarbazepine, St.John’s Wort, rifabutin, rifampicin, primidone, barbiturates, and phenytoin.
• Carbamazepine
• Clarithromycin
• Divalproex
• Mycophenolate Mofetil
• Tranexamic acid
• Insulin
• Aminophylline
• Phenobarbital
• Mycophenolate
• Aprepitant
• Bosentan
• Cobicistat
• Crizotinib
• Dabrafenib
• Eslicarbazepine
• Efavirenz
• Fosaprepitant
• Fosphenytoin
• Nevirapine
• Perampanel
• Topiramate
• Vemurafenib
• Ulipristal

Primolut N may cause an increase in the levels of the following drugs in blood that increases the occurrence of side effects:

• Selegiline
• Ciclosporin

What to do if you skip a dose

If you accidentally skip a dose, take it as soon as you remember. But if it is near the next dose, skip it and take the next dose then continue with the normal schedule. Do not double the intake to compensate for themissed dose. The effectiveness of the drug is reduced if doses are skipped, therefore one can set a reminder or have a family member remind them when it is time to take the drug.

Precautions

A number of precautions should be considered while using Primolut N. The precautions include:

• If you become pregnant while using Primolut N, inform your doctor as the drug is not recommended for use in pregnancy.
• Do not the drug if you are breastfeeding.
• The drug doesn’t interact with alcohol. But it causes dizziness, drowsiness, fatigue and interferes with your vision, it is advised that you avoid the operation of heavy machinery or driving.
• Liver damage. It should be used with caution, and dose adjustment is recommended. In severe cases of liver damage, it should not be used.
• Primolut N should not be used if you have an allergic reaction to its active ingredients or the other components in the drug.
• If you have a pending operation, the drug should be stopped at least six weeks in advance.
• Primolut N should stop being used if it causes severe migraines, a sudden disorder that affects perceptual (vision and hearing), the occurrence of signs of thrombophlebitis, a significant increase in the blood pressure.
• Do not take the drug if the package has been tampered with or the expiry date has passed.
• When taking blood tests, inform your doctor that you taking the medication as it may interfere with a number of laboratory test like thyroid hormone tests.
• While using the drug use non-hormonal form of contraceptives like the barrier methods as condoms and diaphragm.
• Keep all your doctor’s appointments while using Primolut N sothe doctor keeps checking the progress and the likely hood of adverse reactions occurring.
• Benign and malignant tumors in the liver have been reported in patients using hormonal drugs in a rare case, thus contact your doctor immediately if you have severe pain in your abdomen.
• Breast cancer has been diagnosed often in women using hormonal drugs. You should examine your breasts regularly and report to your doctor if you feel lumps that were not there previously.
• Primolut N should not be used to treat other conditions unless advised by the doctor.
• You should not stop taking the drug suddenly or lower the prescribed dose as it might result in unwanted side effects.
• Primolut Nshould not be used in children that have not begun the menstrual cycle.
• Smoking increases the chance that adverse effects may occur, thus talk to your doctor if you are smoking.

Different Brands and Manufacturing Companies of the Drug

Primolut N tablets are manufactured by Zydus Cadila. Brand names of norethisterone are Primolut N and Utovlan. Alternative brands of Primulot N include:

• Cycolunct-N – Global Pharmaceuticals
• Feminor – Wilsons Pharmaceuticals
• Norecyn – ZafaPharmaceuticals Laboratories (PVT) Ltd.
• Rimoluten – Regent Laboratories Ltd.

Substitutes of the drug

Substitutes of Primolut N that have the same strength and work the same way. They include:

• Regestrone 5 mg tablet – Torrent Pharmaceuticals
• Gynaset 5mg tablet – Mankind Pharma Ltd
• Cycloreg 5 mg tablet – Jagsonpal Pharmaceuticals Ltd
• Sysron N 5 mg tablet – Systopic Laboratories Pvt Ltd
• Dub 5 tablet – Obsrge Biotech Ltd
• Nostra 5 mg tablet – Corona Remedies Pvt Ltd
• Norlut-N 5 mg tablet – Cipla Ltd
• Regulate 5 mg tablet – Group Pharmaceuticals Ltd
• Norgest 5 mg tablet – Micro Labs Ltd
• Prevent N 5 mg tablet – Intas Pharmaceuticals Ltd
• Ethinorm P 5 mg tablet – Bennet Pharmaceuticals Ltd
• Promolup N 5 mg tablet – Lupin Ltd
• Gynabest 5 mg tablet – Bastochem Formulations India Ltd.

References

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